Healing of Apical periodontitis-the Effect of Diabetes Mellitus and Tobacco Smoking

Periapical Periodontitis Clinical Trial

Official title:

Healing of Apical Periodontitis After Nonsurgical Endodontic Treatment- the Effect of Diabetes Mellitus and Tobacco Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812171
• Other study ID #: Uniri-biomed-18-53 1183
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: July 3, 2023

Study information

• Verified date: July 2023
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Apical periodontitis is an inflammatory process located around the apex of the root. It is mainly caused by a microbial infection of the pulp space. Diabetes mellitus and tobacco smoking are modulating factors that may influence the healing of apical periodontitis. Present studies have disclosed an association between smoking and apical periodontitis and diabetes mellitus and apical periodontitis. The aim of this study is to compare the healing of periapical bone in smokers and non-smokers and patients with diabetes mellitus type 2 and healthy participants. The hypothesis of this study is that smokers and patients diagnosed with diabetes mellitus will experience slower healing with a lower success rate in comparison to control groups. Apical periodontitis will be diagnosed through means of clinical examination and radiological analysis. Healing of apical periodontitis will be determined using periapical radiographs utilizing periapical index. This prospective study will contribute to the development of clinical guidelines concerning smokers and patients with diabetes mellitus type 2.

Description:

Apical periodontitis is an inflammatory process located around the apex of the root. It is mainly caused by a microbial infection of the pulp space. Diabetes mellitus and tobacco smoking are modulating factors that may influence the healing of apical periodontitis. Present studies have disclosed an association between smoking and apical periodontitis and diabetes mellitus and apical periodontitis. The aim of this study is to compare the healing of periapical bone in smokers and non-smokers and patients with diabetes mellitus type 2 and healthy participants. The hypothesis of this study is that smokers and patients diagnosed with diabetes mellitus will experience slower healing with a lower success rate in comparison to control groups. Apical periodontitis will be diagnosed through means of clinical examination and radiological analysis. Healing of apical periodontitis will be determined using periapical radiographs utilizing periapical index (PAI). One observer will be calibrated by evaluation of periapical status in 100 reference radiographs according to periapical index scoring system .

In each participant only one tooth will be included in the study. This will be first tooth submitted to endodontic treatment according to diagnostic priority. The survey will include only teeth with adequate endodontic treatment according to following criteria: post-operative periapical radiograph demonstrating adequate length and homogeneity of root canal filling (no visible voids, one millimeter shorter than radiologic apex) , and clinically and radiologically adequate permanent crown restoration. Participants will attend clinical and radiological follow-up in six months and one year following root-canal treatment to assess healing rate. In diabetic participants glycemic control will be determined according to the level of glycated hemoglobin, which is routine procedure in these patients. In smokers, intensity and duration of smoking habit will be recorded. This prospective study will contribute to the development of clinical guidelines concerning smokers and patients with diabetes mellitus type 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

1. Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment

• Smoker group- everyday cigarette smoking habit, older than 18 years

• Control group-healthy non-smoker patients, older than 18 years, paired with smoker group according to age and sex

2. Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment

• Diabetic group-patients having type 2 diabetes mellitus, older than 18 years, non-smokers

• Control group-healthy patients, non-smokers, older than 18 years, paired with diabetic group according to age and sex

Exclusion Criteria:

1. Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment

• Smoker group-systemic disease, pregnancy, taking medications that interfere with bone metabolism and immunologic response, former and occasional smokers

• Control group-former, occasional and present smokers,systemic disease, pregnancy, taking medications that interfere with bone metabolism and immunologic response

2. Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment Diabetic group-pregnancy, taking medications that interfere with bone metabolism and immunologic response, smokers Control group-patients having diabetes mellitus, pregnancy, taking medications that interfere with bone metabolism and immunologic response, smokers

Related Conditions & MeSH terms

• Diabetes Mellitus
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• non-surgical endodontic treatment
standard non-surgical endodontic treatment performed by endodontic specialist

Locations

Country	Name	City	State
Croatia	University of Rijeka Faculty of Dental Medicine	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
Romana Peršic Bukmir	University of Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of smoking habit on apical periodontitis healing after non-surgical endodontic treatment	Comparison of apical periodontitis healing in smoker and non-smoker participants	one year
Primary	Influence of diabetes mellitus on apical periodontitis healing after non-surgical endodontic treatment	Comparison of apical periodontitis healing in diabetic and non-diabetic participants	one year
Secondary	Association of smoking intensity and duration with apical periodontitis healing	Calculation of association of smoking intensity and duration with apical periodontitis healing rate	one year
Secondary	Association of glycated hemoglobin level (HbA1C) with apical periodontitis healing	Calculation of association of glycated hemoglobin level (HbA1C) with apical periodontitis healing rate	one year